PURPOSE:To present the outcomes of the York-Mason procedure for managing recto-urethral fistula (RUF) after robot-assisted radical prostatectomy (RARP). METHODS:A single-center retrospective cohort study was conducted at the Antoni van Leeuwenhoek Hospital-Netherlands Cancer Institute. Between January 2011 and May 2024, 12 cases of RUF following RARP, all treated with the York-Mason technique, were identified. Initial treatment involved conservative management with prolonged catheterization. If unsuccessful, surgical intervention followed. The York-Mason procedure is a posterior transsphincteric approach, providing direct access to the fistula through healthy tissue, with precise layer-by-layer closure of the sphincter complex. Successful repair was defined as the absence of anal urinary loss, the absence of fecal material in the catheter bag or pneumaturia, and the absence of leakage on cystogram. RESULTS:Of the 12 cases of RUF, 10 occurred in patients who underwent RARP without radiotherapy (RARP-only), and 8 of these underwent York-Mason procedure as initial surgical treatment, achieving a 100% success rate after a median follow-up of 5.1 years (SD 2.9). The remaining two RARP-only patients initially underwent other surgical interventions, after which one achieved successful closure with subsequent York-Mason repair. The other two patients received both RARP and radiotherapy before fistula detection- one received radiotherapy prior to RARP, and one after. York-Mason was effective when radiotherapy preceded RARP. CONCLUSION:The York-Mason procedure provides promising results for managing RUFs in patients who have undergone RARP without salvage radiotherapy. Its effectiveness is particularly evident when used as the first surgical intervention.
Background and objective Image-guided surgical navigation (IGSN) can enhance surgical precision and safety. The expansion of minimally invasive surgery has increased the demand for integration of these navigation systems into robot-assisted surgery. Our objective was to evaluate the integration of electromagnetic tracking with IGSN in robot-assisted sentinel lymph node biopsy (SLNB). Methods We conducted a prospective feasibility study to test the use of IGSN in SLNB. In total, 25 patients scheduled for SLNB at The Netherlands Cancer Institute were included (March 2022 to March 2023). SLNB using IGSN was performed using a standardised technique with a da Vinci robot (Intuitive Surgical, Sunnyvale, CA, USA) in four-arm configuration. Feasibility was determined as the percentage of sentinel nodes (SNs) successfully identified via IGSN. Successful SN resection was defined as SNs correctly localised via navigation and validated ex vivo with a gamma probe. Surgeon feedback on the robot-assisted IGSN workflow was evaluated using the System Usability Scale (SUS). Key findings and limitations In accordance with the protocol, the first five patients were used for workflow optimisation, and the subsequent 20 patients were included in the analysis. IGSN led to successful identification of 91% (50/55) of the SNs. There were no complications associated with navigation. The surgeon feedback (SUS) was 60.9, with lowest scores reported for the user interface and workflow integration. Conclusions IGSN during robot-assisted surgery was feasible and safe. The technique allowed identification and removal of predefined small pelvic lymph nodes. Patient summary We carried out a study on the feasibility of imaging-guided navigation in robot-assisted prostate surgery. Our results show that this technique is feasible, safe, and effective.
OBJECTIVE:To investigate whether combination treatment of prostate-specific membrane antigen (PSMA)-based radioguided surgery (RGS) with short-term androgen deprivation therapy (ADT) improves oncological outcomes in men with oligorecurrent prostate cancer (PCa) as compared to treatment with short-term ADT only. METHODS:The TRACE-II study is an investigator-initiated, prospective, randomised controlled clinical trial. Patients (aged >18 years) with hormone-sensitive recurrent PCa after radical prostatectomy or radiotherapy (brachytherapy or external beam radiotherapy), with involvement of ≤2 lymph nodes or local oligorecurrent disease within the pelvis as determined by PSMA positron emission tomography (PET)/computed tomography (CT) are randomly assigned in a 1:1 ratio between 6-month ADT (Arm A) or 6-month ADT plus RGS (Arm B). The primary objective is to determine clinical progression-free survival (CPFS) at 24 months. After PSMA-RGS, CPFS is defined as the time between the start of treatment and the appearance of a re-recurrence (any N1 or M1) as suggested by PSMA-PET/CT or symptoms related to progressive PCa, or death from any cause. The secondary objectives include metastasis-free survival at 2, 5 and 10 years, biochemical progression-free survival at 2 years, and patient-reported quality of life at 2, 5 and 10 years. A total of 60 patients, 30 per arm, will be included. The trial is powered (80%) to detect at least a 30% absolute difference in CPFS between the two study arms in the period 2 years after randomisation. We expect to enrol the required participants in 3 years. The study has an expected duration of 5 years in total. CONCLUSIONS:Combining RGS with short-term ADT might be oncologically beneficial for patients with oligorecurrent PCa. In this first randomised controlled trial, we are investigating the potential oncological benefits of this combined treatment, while also focusing on maintaining quality of life.
BACKGROUND:The invasive nature of extended pelvic lymph node dissection (ePLND) prompts the need for alternative lymphatic mapping technologies. To change the focus to "sparing nodes that are not involved," the first step is to research the feasibility of intraoperatively distinguishing the lymph drainage patterns of the prostate from healthy organs. METHODS:We performed a prospective study (NCT05120973) that included 16 patients who underwent a robot-assisted radical prostatectomy + ePLND + sentinel node (using indocyanine green-99mTc-nanocolloid). After general anesthesia, a second fluorescent dye (fluorescein) was injected unilaterally in two deposits into the intradermis of the upper leg (n = 8) or abdominal wall (n = 8), because these are the most common locations of lymphedema in prostate cancer surgery. To distinguish between the drainage patterns, in vivo and ex vivo multispectral fluorescence imaging was performed by using a fluorescence endoscope. RESULTS:Indocyanine green and fluorescein were visible in the same regions within the ePLND-template and co-accumulated in lymph vessels in vivo. At histopathology, fluorescein was seen in only 10 of 370 lymph nodes (possibly owing to tracer properties), none of which overlapped with indocyanine green and none were tumor-positive. Administration of fluorescein did not result in discomfort or abnormal postoperative recovery. CONCLUSIONS:Multispectral imaging can be used to distinguish lymphatic drainage patterns. Our in vivo findings indicate that within the ePLND-template, lymphatic drainage patterns of the prostate at least partly overlap with those of upper leg and abdominal wall. The properties of fluorescein render it unsuitable for confirmation of fluorescence at histopathology.
Background and objectiveThe implementation of quality assurance programs (QAPs) within urological practice has gained prominence; yet, their impact on outcomes after radical prostatectomy (RP) remains uncertain. This paper aims to systematically review the current literature regarding the implementation of QAPs and their impact on outcomes after robot-assisted RP, laparoscopic RP, and open prostatectomy, collectively referred to as RP.MethodsA systematic Embase, Medline (OvidSP), and Scopus search was conducted, according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) process, on January 12, 2024. Studies were identified and included if these covered implementation of QAPs and their impact on outcomes after RP. QAPs were defined as any intervention seeking quality improvement through critically reviewing, analyzing, and discussing outcomes. Included studies were assessed critically using the Risk of Bias in Nonrandomized Studies of Interventions (ROBINS-I) tool, with results summarized narratively.Key findings and limitationsTen included studies revealed two methodological strategies: periodic performance feedback and surgical video assessments. Despite conceptual variability, QAPs improved outcomes consistently (ie, surgical margins, urine continence, erectile function, and hospital readmissions). Of the two strategies, video assessments better identified suboptimal surgical practice and technical errors. Although the extent of quality improvements did not appear to correlate with the frequency of QAPs, there was an apparent correlation with whether or not outcomes were evaluated collectively.Conclusions and clinical implicationsCurrent findings suggest that QAPs have a positive impact on outcomes after RP. Caution in interpretation due to limited data is advised. More extensive research is required to explore how conceptual differences impact the extent of quality improvements.Patient summaryIn this paper, we review the available scientific literature regarding the implementation of quality assurance programs and their impact on outcomes after radical prostatectomy. The included studies offered substantial support for the implementation of quality assurance programs as an incentive to improve the quality of care continuously.
Background Metastatic retroperitoneal lymph node dissection (LND) for nodal recurrence is applied for a variety of cancers, such as urological, gynaecological and rectal cancer. Precise localisation and resection of these lymph nodes (LNs) during surgery can be challenging, especially after previous radiotherapy or surgery. The objective of this study was to assess the added value of surgical navigation for targeted LND in the retroperitoneum. Methods We performed an open-label randomised, controlled, phase 3 trial at the Netherlands Cancer Institute, Amsterdam. Eligible participants were over 18 years of age, scheduled for targeted retroperitoneal LND by laparotomy, with removal of one or more suspected (targeted) LN(s) as assessed by diagnostic imaging. Patients were randomised (1:1) between conventional LND and LND using surgical navigation, by means of a minimisation method stratified fi ed for tumour origin (urological, colorectal and other). For the surgical navigation, a digital 3D model of the patients' ' anatomy was created from diagnostic CT scans, including delineation of the targeted LN(s). The 3D model was linked to the patients' ' position in the operation room. Using an electromagnetic tracking system, with a sterile tracked pointer, the actual position of the pointer was shown in the 3D model, enabling the surgeon to localize the targeted LN(s). The primary outcome of the study was the percentage of successful procedures. Success was defined fi ned as no residual target LN(s) visible on postoperative CT imaging. This study was registered with ClinicalTrials.gov, NCT05867095. Findings From January 2017 to December 2020, 69 participants were included in the study, 35 (51%) in the conventional arm and 34 (49%) in the navigation arm. Four patients were not evaluable and excluded from further analysis; three in the conventional arm (patients withdraw from study participation), one in the navigation arm (discontinued surgery, misclassified fi ed diagnosis). According to intention-to-treat analysis, 50% (16/32) of the surgical procedures was successful in the conventional arm, versus 85% (28/33) in the surgical navigation arm (one-tailed p = 0.0028, 90% CI: 14%-56%). - 56%). Using the Clavien-Dindo classification, fi cation, the overall complication rate was comparable between the conventional arm and the navigation arm. Surgeons judged the surgical navigation setup as valuable, the median preference score to use surgical navigation was 3.7 (3.3-4.0) - 4.0) (scale 1-5), - 5), and the median system usability score was 75 (70-85) - 85) (scale 0-100). - 100). Interpretation Surgical navigation allows for significantly fi cantly better localisation and removal of target LN(s) in the retroperitoneum.
Our objective was to assess the diagnostic value of the sentinel node (SN) procedure for lymph node staging in primary intermediate- and high-risk prostate cancer patients with node-negative results on prostate-specific membrane antigen PET/CT (miN0). Methods: From 2016 to 2022, 154 patients with primary, miN0 PCa were retrospectively included. All patients had a Briganti nomogram-assessed nodal risk of more than 5% and underwent a robot-assisted SN procedure for nodal staging. The prevalence of nodal metastases at histopathology and the occurrence of surgical complications according to the Clavien-Dindo classification were evaluated. Results: The SN procedure yielded 84 (14%) tumor-positive lymph nodes with a median metastasis size of 3 mm (interquartile range, 1-4 mm). In total, 55 patients (36%) were reclassified as pN1. A complication of Clavien-Dindo grade 3 or higher occured in 1 patient (0.6%). Conclusion: The SN procedure classified 36% of patients with miN0 prostate cancer with an elevated risk of nodal metastases as pN1.
To determine the diagnostic accuracy of the hybrid tracer indocyanine green (ICG)-Technetium-99 m(99mTc)-nanocolloid compared to sequential tracers of 99mTc-nanocolloid and free-ICG in detecting tumor-positive lymph nodes (LN) during primary surgery in prostate cancer (PCa) patients. Image-guided surgery strategies can help visualize individual lymphatic drainage patterns and sentinel lymph nodes (SLNs) in PCa patients. For lymphatic mapping radioactive, fluorescent and hybrid tracers are being clinically exploited. In this prospective randomized phase II trial, we made a head-to-head comparison between ICG-99mTc-nanocolloid (hybrid group) and 99mTc-nanocolloid and subsequent free-ICG injection (sequential group). PCa patients with a >5
Primary intra- or transabdominal transplantation of an extended rectus abdominis myocutaneous (ERAM) flap may help prevent surgical complications of pelvic resections. Surgical delay of the ERAM flap may help prevent intra-abdominal (partial) flap loss after transplantation in highly complex situations including previous irradiation. We report on the outcome of this approach and the risk-factors associated with an eventful outcome. From 2012 to 2020, 105 delayed ERAM flaps were consecutively applied immediately following extended pelvic resections after chemoradiation or hyperthermic intraperitoneal chemotherapy. We addressed the increased reconstructive demands by designing the flap in line with the 10(th) rib and delaying the flap's skin island. All post-operative complications were assessed in light of patient-related or procedure-related potential risk-factors. Major complications occurred in 39 patients. These were correlated with surgery for residual or recurrent malignancy (p < 0.01), with tip necrosis after flap delay (p = 0.02), and with the use of a mesh to close the abdominal donor site (p < 0.01). (Partial) flap loss occurred in 4 cases. We observed a comparably high rate of major complications after ERAM transplantations for increasingly extending indications of perineal-pelvic resections. We consider this to be attributable to poorer patients' conditions and disease processes, rather than to flap viability. Delay of the flap allowed for the use of large and voluminous flaps with comparably little (partial) flap loss.
Background: Accurate identification of men who harbor nodal metastases is neces-sary to select patients who most likely benefit from whole pelvis radiotherapy (WPRT). Limited sensitivity of diagnostic imaging approaches for the detection of nodal micrometastases has led to the exploration of the sentinel lymph node biopsy (SLNB). Objective: To evaluate whether SLNB can be used as a tool to select pathologically node-positive patients who likely benefit from WPRT. Design, setting, and participants: We included 528 clinically node-negative primary prostate cancer (PCa) patients with an estimated nodal risk of >5% treated between 2007 and 2018. Intervention: A total of 267 patients were directly treated with prostate-only radio-therapy (PORT; non-SLNB group), while 261 patients underwent SLNB to remove lymph nodes directly draining from the primary tumor prior to radiotherapy (SLNB group); pN0 patients were treated with PORT, while pN1 patients were offered WPRT. Outcome measurements and statistical analysis: Biochemical recurrence-free survival (BCRFS) and radiological recurrence-free survival (RRFS) were compared using propensity score weighted (PSW) Cox proportional hazard models. Results and limitations: The median follow-up was 71 mo. Occult nodal metastases were found in 97 (37%) SLNB patients (median metastasis size: 2 mm). Adjusted 7-yr BCRFS rates were 81% (95% confidence interval [CI] 77-86%) in the SLNB group and 49% (95% CI 43-56%) in the non-SLNB group. The corresponding adjusted 7-yr RRFS rates were 83% (95% CI 78-87%) and 52% (95% CI 46-59%), respectively. In the PSW multivariable Cox regression analysis, SLNB was associated with improved BCRFS (hazard ratio [HR] 0.38, 95% CI 0.25-0.59, p < 0.001) and RRFS (HR 0.44, 95% CI 0.28-0.69, p < 0.001). Limitations include the bias inherent to the study's Conclusions: SLNB-based selection of pN1 PCa patients for WPRT was associated efit from the addition of pelvis radiotherapy. This strategy results in a longer dura (c) 2023 The Author(s). Published by Elsevier B.V. on behalf of European Association of Urology. This is an open access article under the CC BY license (http://creativecommons.